N/A
N=41
Computer-Based Treatment for Social Anxiety Disorder
Social Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03415022 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change in Percent Dwell Time on Threat Faces — 20.7; 27.1 percentage of dwell time on threat faces
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- computer-based treatment (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Dwell Time on Threat Faces |
20.7; 27.1 | — |
| PRIMARY Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) |
23.68; 22.38 | — |
| SECONDARY Change in Total Score of Social Phobia Inventory (SPIN) |
17.7; 10.1 | — |
| SECONDARY Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire |
-8.8; -4.8 | — |
| SECONDARY Change in Total Score of the Revised Social Anhedonia Scale |
1.7; 1.8 | — |
| SECONDARY Change in Total Score of the Snaith Hamilton Pleasure Scale |
2.2; -1.0 | — |
| SECONDARY Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version |
1.8; 1.8 | — |
| SECONDARY Clinical Global Impression-Change Scale |
2.8; 2.7 | — |
Summary
The present study is an open trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)
Eligibility Criteria
Inclusion Criteria
- Males and females between the ages of 18 and 60
- Current primary diagnosis of SAD
- Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version)
- Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol
- Normal or corrected-to-normal vision
Exclusion Criteria
- Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
- Current severe depression
- Suicidal ideation or behavior
- Current diagnosis of posttraumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
- Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
- Current unstable or untreated medical illness
- Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders allowed)
- Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months
- Any concurrent cognitive behavioral therapy; other psychotherapy that was initiated in the past 3 months
- Pregnancy, or plans to become pregnant during the period of the study - will be assessed by urine
- Contraindication to MRI scanning:
- Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
- Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
Data sourced from ClinicalTrials.gov (NCT03415022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.